Employer: iFirst Medical Technologies
Job Title: Bio Medical Engineer
Location: Honolulu, Hawaii or West Coast USA
Hours: 40 hours plus, per week
Start Date: 3-1-17
Term: Contract to start
Compensation: Negotiable Bio
iFirst provides radical improvements to existing diagnostic and applications. This approach allows iFirst to enter markets with minimal risk and quick FDA approval. Our diagnostic platform focuses on high impact and large markets. Our first product will target blood coagulation, which is the second most common diagnostic in the market.
Design and execute tests to simulate product use for verifying and validating product performance, reliability, and usability.
- Provide medical expertise and knowledge to support the clinical development activities in positioning diagnostics tests in the relevant clinical setting to ensure optimal clinical development and commercial positioning for end users and strategic partners.
- Provide clinical guidance, support and education to customers as well as prospective customers, participate in the development of marketing material for use in hospital, clinician office, and reference lab settings. Support sales and marketing through presentations at customer sites, congresses and symposia.
- Provide strong scientific, medical developmental leadership for the company. Function as a key company liaison with KOLs, Scientific/Medical Advisors, DSMB’s, Board of Directors, and Investors.
- Process and interpret data from trials including outcomes and findings leading to recommendations on clinical development and regulatory filing strategies.
- Willingness to be hands-on with trial recruitment activities and visiting clinical sites.
- Ensure that all clinical programs are conducted according to appropriate medical/scientific standards, on time and within budget.
- Manage the presentation of key clinical findings to internal and external stakeholders, including iFirst’s Board of Directors and venture fund partners on request.
- Support regulatory activities, as assisted by VP Regulatory Affairs, who will be a direct report by contributing to key regulatory submission writing and strategic positioning with FDA and other regulatory agencies.
- Keep abreast of emerging models in health care delivery; identify and define new and innovative strategies to achieve business goals and objectives.
- Monitor the competitive landscape closely and assist the company in adapting its strategy in response to changes in the external environment.
- Provide input for budget development – working closely with the Chief Operating Officer, Chief Executive Officer and SVP of Finance.
- Build upon and maintain the existing clinical network with external medical/scientific experts and key opinion leaders.
- Represent the company on the “sell-side” in any discussions/presentations with potential partners and present data at appropriate forums such as medical and scientific conferences.
Position Description / Duties
Desired Qualifications / Experience
- BS in Engineering (Mechanical, Chemical, Bioengineering, or Biomedical), MS preferred
- 2 years experience in the establishment of human factors engineering requirements / standards, will consider university experience
- Experience with operating in a regulated environment (i.e. FDA) and implications for medical device and healthcare applications
- Understanding of design requirements, development, verification, risk documentation and validation for medical devices
- Understanding of Quality System Regulations (QSR)